Gilead Sciences Receives the US FDA Advisory Committee’s Recommendation on Approval of Descovy for PrEP

Shots:

• The US FDA advisory committee voted 16 to 2 for Descovy’s approval to treat proposed indication of pre-exposure prophylaxis (PrEP) in men and transgender women (TGW) who have sex with men
• The committee reviewed the P-III DISCOVER global trial data assessing Descovy vs Truvada in men and transgender women who have sex with men and are at high-risk for sexually acquired HIV infection and resulted in non-inferiority data, improvement in renal and bone laboratory parameters
• Additionally, the committee reviewed PK data for HIV and PrEP treatment in cis-gender (not part of DISCOVER study) and voted 10 out of 8 as the data was not adequate in regards to efficacy. Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablet; F/TAF) is indicated in combination with antiretroviral agents for HIV infection in patients weighing at least 35 kg. The product also has a boxed warning of Post Treatment Acute Exacerbation of Hepatitis B

Click here to­ read full press release/ article | Ref: Gilead | Image: Twitter